Efficacy and safety of Ashwagandha Root Extract on Sexual Health in Healthy Women: Findings of a Prospective, Randomized, Double-Blind, Placebo-Controlled Study

Background: Ashwagandha is an herbal extract known for its potential benefits on various aspects of human health, including stress reduction and hormone regulation. Objective: This prospective, randomized, double-blind, placebo-controlled study investigated the role of Ashwagandha Root Extract (ARE) in enhancing sexual function in healthy women with Female Sexual Dysfunction (FSD). Materials and Methods: Sixty-two healthy women aged 18-50 years were randomly assigned to receive Ashwagandha root extract (ARE) 600mg/d (n=31), or identical placebo (n=31) for 8 weeks. Study assessments were done at baseline, week 2, week 4, and week 8. The primary outcome was Female Sexual Function Index (FSFI) scores, whereas secondary outcomes were Female Sexual Distress Scale (FSDS-R), Satisfying Sexual Encounters (SSEs), Perceived Stress Scale (PSS-10), and Quality of Life (SF-12 QoL) assessed at all visits. Laboratory assessments included serum sex hormones (Follicle-Stimulating Hormone (FSH), Luteinizing Hormone (LH), Progesterone, Estrogen- E2, Prolactin, and Testosterone), liver enzymes and renal parameters estimated at baseline and week 8. Results : One patient was lost to follow-up and data of 61 (31 ARE, 30 placebo) patients was included for efficacy analysis. ARE significantly improved the mean (SD) FSFI total scores from 51.65 (10.23) at baseline to 71.94 (10.33) at week 8 as compared to placebo 51.77 (9.68) and 61.83 (8.38) baseline and week 8 respectively (p=0.002). This improvement was observed in ‘desire’ and ‘sexual satisfaction’ domains of FSFI scale. Similarly, assessments of sexual activity (SSE) shows greater improvements with ARE in ‘satisfying sexual events’ and ‘sexual desire’ (p<0.0001). The scores for PSS (p=0.0009), and SF-12 (p=0.044) were better with ARE compared to placebo at week 8. No significant changes or abnormalities were observed for hormones. Only one woman with placebo reported mild dizziness. Conclusion: Ashwagandha root extract holds promise as a safe and effective option for improving sexual health in women.